Kornimate/medical-research-clean huggingface dataset:
mico - mirena or conventional medical treatment for menorrhagia

Conditions: Idiopathic Menorrhagia

Summary: the aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of mirena in treatment of heavy menstrual bleeding (menorrhagia) under daily-life treatment conditions.for each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.

the "mico - mirena or conventional medical treatment for menorrhagia" study consist of two parts, mico asia-pacific and mico ma0901 (rest of world). data from both parts will be analysed in separate pools as well as in a global pool. the trial alias are impact nos. 14697 (nct00864136), 14536.

Eligibility criteria:
inclusion criteria: * women between the ages of 18-45 (inclusive) not intending to become pregnant during the next year * women complaining of heavy menstrual bleeding over several consecutive cycles * women without structural or histological abnormality of the uterus, or with fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (eligible for pharmaceutical treatment according to the nice guideline 2007) * informed consent (where required by laws or regulations) exclusion criteria: * the contraindications and warnings of the respective summary of product characteristics (mirena®, combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed. * women taking hormone replacement therapy * women with symptoms such as intermenstrual or post-coital bleeding, unless an endometrial biopsy has been performed and pathology excluded * women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm (nice guideline 2007) * women on anticoagulative therapy or other treatment (including e.g. copper iud use) known to cause menorrhagia

Keywords: menorrhagia
effect of dietary supplemental fish oil in alleviating health hazards associated with air pollution

Conditions: Oxidative Stress; Inflammation; Blood Pressure; Vasoconstriction; Coagulation; Pulmonary Function

Summary: this study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary alterations linked to air pollution

the investigators conduct a randomized controlled trial among 70 healthy college students in shanghai, china. these students fulfilling the recruitment criteria will be randomly divided into two parallel groups to receive either fish oil \[marine-derived n-3 polyunsaturated fatty acids (pufa)\] or sunflower seed oil. participants in fish oil group receive 2.5 g/day (two 1.25-g capsules daily) in divided doses. the sunflower seed oil capsules are identical. all interventions started at 7:30 a.m.to avoid issues related to diurnal variation. health endpoints, including blood pressure, skin color, fractional exhaled nitric oxide and pulmonary function were evaluated and biological samples such as morning urine, fast blood, saliva sample,buccal cells and skin tape stripping will be collected at week 1 before supplemenatation, and week 8, week 10, week 12 as well as week 14 during the supplementation phase.the investigators measure personal real-time exposure to pm2.5 and personal temperature and relative humidity.

Eligibility criteria:
inclusion criteria: * equal to or older than 18 years old. * no history of smoking and alcohol addiction. * no chronic diseases or respiratory or allergic diseases,such as hypertension,diabetes,chronic obstructive pulmonary disease,other respiratory/cardiovascular diseases, asthma, rhinitis or other allergic diseases reported by volunteers. * no allergies to n-3 pufa or fish. exclusion criteria: * current smokers or ever smokers * chronic drug use due on cardiovascular or respiratory diseases * participants are taking fish oil,anti-inflammatory drugs, or antioxidant supplements (such as vitamin c or vitamin e)

Keywords: biomarker fish oil oxidative stress air pollution cardiopulmonary system
evaluation of the performance of a new adhesive strip

Conditions: Ileostomy - Stoma

Summary: this study investigates the performance of a new adhesive strip when impacted by output.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent 2. be at least 18 years of age and have full legal capacity 3. have had a stoma for more than one year 4. have intact skin on the area used in the evaluation 5. has a stoma with a diameter up to (≤) 35 mm 6. have a peristomal area accessible for application of adhesive strips (assessed by investigating scientist) exclusion criteria: 1 currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 3. are pregnant or breastfeeding 4. having dermatological problems in the peristomal or abdominal area (assessed by investigating scientist) 5. actively participating in other interventional clinical investigations or have previously participated in this investigation.
study to compare marginal bone loss around implants from two dental implant systems.

Conditions: Jaw, Edentulous, Partially

Summary: the purpose of this study is to compare marginal bone level changes between astra tech implant system; fixture st and biomet 3i; osseotite® implants. subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. implants will be loaded within 15 weeks from installation. the subjects will be followed for 3 years.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * age 18 - 75 years * partial edentulism, kennedy class i or ii, last natural tooth must be cuspid or first bicuspid * edentulous in the area/s if implant placement for more than 2 months exclusion criteria: * untreated caries and/or periodontal disease of residual dentition * need for pre-surgical bone or soft tissue augmentation in the planned implant area/s. * absence of occlusal stability in centric occlusion * any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * pregnancy * present alcohol or drug abuse * tobacco smoking during the last 6 months * unable or unwilling to return for follow-up visits for a period of 3 years
single ascending doses of ggf2 in patients with left ventricular dysfunction and symptomatic heart failure

Conditions: Heart Failure

Summary: study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of ggf2 in patients with heart failure.

phase 1, double-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of ggf2 in cohorts of patients with left ventricular dysfunction and symptomatic heart failure.

Eligibility criteria:
inclusion criteria: 1. left ventricular ejection fraction (lvef) between 10% and 40%. 2. male or female, aged 18 to 75 years, inclusive. exclusion criteria: 1. received any investigational agent or participation in any clinical study of an investigational agent or investigational therapy up to 30 days prior to the screening visit. 2. use of any new prescription medication up to 14 days prior to receiving investigational drug. 3. patients with known specific hepatic disease; bilirubin \>2 mg/dl, sgot \> 100 iu. 4. patients with a history of hepatic impairment (hepatitis b and c). 5. serum creatinine \>2.5 mg/dl. 6. documented stroke or transient ischemic attack (tia) within 60 days of study enrollment.
study of vi-0521 compared to placebo in treatment of diabetes and obesity in adults with obesity-related co-morbid conditions

Conditions: Obesity; Type 2 Diabetes

Summary: the purpose of this study is to evaluate the efficacy and safety of vi0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.


Eligibility criteria:
inclusion criteria: * informed consent * bmi ≥ 27 (no lower bmi limit for type 2 diabetics) * 70 years of age or less * have 2 or more of the following obesity-related co-morbid conditions: * systolic blood pressure 140-160 mmhg (130-160 if diabetic); * diastolic blood pressure 90-100 mmhg (85-100 if diabetic); * requirement for 2 or more medications to achieve control (\<140/90 mmhg) * triglyceride level between 200-400 mg/dl or requirement for 2 or more medications to achieve control (\<200 mg/dl) * at lease one of the following metabolic criteria: * fasting blood glucose level \> 100 mg/dl * glucose level \> 140 mg/dl * diagnosis of type 2 diabetes * waist circumference ≥ 102 cm for men or ≥88 cm for women exclusion criteria: * stroke/mi/unstable cardiovascular disease within 6 months * clinically significant renal, hepatic or psychiatric disease * unstable thyroid disease or replacement therapy * nephrolithiasis * obesity of known genetic or endocrine origin * participation in a formal weight loss program or lifestyle intervention * glaucoma or intraocular pressure * pregnancy or breastfeeding * drug or alcohol abuse * smoking cessation within previous 3 months or plans to quit smoking during study * eating disorders * cholelithiasis within past 6 months * excluded medications * type 1 diabetes or use of any antidiabetic medication other than metformin * previous bariatric surgery * bipolar disorder or psychosis * steroid hormone therapy * systolic blood pressure \> 160 mmhg, diastolic blood pressure \> 100 mmhg * creatinine clearance \< 60 ml/minute

Keywords: obesity, type 2 diabetes
adjunctive local sodium hypochlorite gel in non surgical periodontal debridement

Conditions: Periodontal Diseases

Summary: the aim of this study was to assess the efficacy of minimally invasive nonsurgical debridement (minsd) of periodontal pockets with or without local amino acid buffered sodium hypochlorite (naocl) gel application after 6 months follow-up.

forty periodontal compromised patients were randomly allocated in two groups. periodontal pockets \> 5 mm in patients of test group were treated by minsd and naocl gel application, meanwhile in patients of control group minsd alone was performed. full-mouth plaque score (fmps) , full-mouth bleeding score (fmbs), probing depth (pd), clinical attachment level (cal) and gingival recession (gr) were assessed at baseline and after 6 months follow-up.

Eligibility criteria:
inclusion criteria: * patients diagnosed with periodontitis; * age \> 18 years old; * patients with at least 10 teeth for arch; * presence at least of two teeth with pd \> 5 mm for quadrant; * single-rooted and multi-rooted teeth; exclusion criteria: * patients with systemic diseases; * pregnant or lactating; * tobacco smokers (\> 10 cigarettes/day); * previous periodontal treatment in the last 2 years; * prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy; * furcation involvement; * acute periodontal or endodontic abscess; * third molars
acute and chronic effects of ecologic barrier© on mood and cognition

Conditions: Cognitive Change; Mood

Summary: this study aims to investigate the acute and chronic effects of an 8 week probiotic intervention (ecologic barrier©) on mood and cognitive outcomes in healthy adults.

this study will employ a double-blind, randomised, placebo-controlled crossover design to investigate the acute and chronic effects of an 8 week probiotic intervention (ecologic barrier©) on mood and cognitive outcomes in healthy older adults. a total of 30 participants will be enrolled and counterbalanced to receive the active probiotic treatment (2g per day ecologic barrier©) or a matched placebo in the first arm, before having a 4 week washout period and continuing with 8 weeks of the second treatment not consumed within the first arm. outcome measures will be assessed at baseline, 24 hours and 8 weeks within each arm. these will include cognitive measures of affective processing, immediate and delayed verbal memory, visuospatial working memory and executive functions, and mood measures of depressive symptoms, cognitive reactivity, anxiety, stress and general mood. in addition, faecal samples will be collected at all timepoints in order to explore faecal microbiota profiles before and after probiotic treatment.

Eligibility criteria:
inclusion criteria: * aged between 65 - 80 * agree not to not consume probiotic or prebiotic supplements or live yoghurt throughout the course of study. * proficient in the english language exclusion criteria: * already a habitual user of probiotics * antibiotic treatment within last 3 months * current diagnosis of and not currently receiving treatment for mental health disorder * gastrointestinal disorder * allergic to any ingredient of the active or placebo treatment * regular smoker * diabetes mellitus
clinical comparison of different adhesives in nccls

Conditions: Tooth Wear

Summary: the aim of this randomized, controlled, prospective clinical trial is to evaluate the performances of a universal adhesive in three different application modes, a self-etch adhesive and an etch\&rinse adhesive in restoration of non-caries cervical lesions. thirty-four patients will receive restorations. lesions will be divided into 5 groups according to adhesive systems and application modes: cu-se: clearfil universal bond quick in self-etch mode, cu-sle: clearfil universal bond quick in selective etch mode, cu-er: clearfil universal bond quick in etch\&rinse mode, cse: clearfil se bond, tb: tetric n-bond. restorations (tetric n-ceram composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified usphs criteria after 48 months. two examiners who is not involved in the placement of restorations will conduct the evaluations. descriptive statistics will be performed using chi-square tests.


Eligibility criteria:
inclusion criteria: * being 18 years or older, * having no medical or behavioral problems preventing then from attending review visits, * having at least 5 tooth with nccls * having antagonist teeth exclusion criteria: * poor gingival health, * uncontrolled, rampant caries, * bruxism, * removable partial dentures, * xerostomia
the effects of intraoperative esketamine on postoperative pain and mood in patients with inflammatory bowel disease

Conditions: Crohn Disease; Depression; Esketamine

Summary: crohn's disease (cd) is a chronic inflammatory disease of the gastrointestinal tract with symptoms evolving in a relapsing and remitting manner. typically, the peak incidence of cd is 18 to 35 years , which means that patients with cd will be plagued by the disease during their most precious years, and nearly 35% of them will develop depressive symptoms. for 70% of patients with cd who need surgery, the incidence of preoperative depression may be higher. the cd cohort with diagnosable psychological condition has been shown to experience a higher rate of disease exacerbation than the cd cohort without psycho complication. at the same time, this depressive mood may make postoperative recovery more difficult, so it is necessary to alleviate postoperative depression. ketamine, a widely used anesthetic, is also used to treat depression. the most used ketamine in clinical practice is racemic ketamine, but its use is associated with many complications such as psychotic adverse effects and neurotoxicity. in recent years, s-ketamine has received attention for better efficacy and fewer complications . in 2019, the food and drug administration (fda) approved s-ketamine nasal spray for the treatment of refractory depression and subsequently received approval from numerous health authorities around the world. this proves that s-ketamine can provide a rapid antidepressant effect in patients with depression in a non-surgical setting. however, it is inconclusive whether s-ketamine affects surgical patients, mainly because of differences in the type of surgery, the dosage administered, the interaction with analgesics, and the evaluation tools implemented. studies have shown that small doses of s-ketamine in breast cancer surgery and cervical cancer surgery can reduce postoperative depression. however, the effects of s-ketamine on postoperative depression (pod) and pain in patients with cd have not been studied.


Eligibility criteria:
inclusion criteria: 1. subjects who volunteered and signed informed consent for the trial, (b) patients aged between 18 and 60, (c) patients with cd who underwent surgery, (d) american society of anesthesiologists (asa) grade ⅰ\~ⅲ, (e) hamilton depression score 8-24. exclusion criteria: 1. allergy to narcotic drugs or ketamine used, (b) patients with other serious systemic diseases (including severe heart, kidney, and liver disease), (c) chronic opioid therapy (more than twice a week for more than three months), (d) inability to understand the digital pain scale, (e) hamilton depression score \ 24.
vitamin d therapy in patients with systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to test the safety and effectiveness of different doses of vitamin d in patients with systemic lupus erythematosus (sle). a long term goal is to determine if vitamin d could be used as a treatment and/or preventative of sle.


Eligibility criteria:
inclusion criteria: * sle by acr criteria (revised 1997) * african american, participating in the sle in gullah health (sleigh) study * outpatient * stable disease with no bilag a or b in any system for the past 4 weeks * stable prednisone (or equivalent corticosteroid) dose ≤ 20 mg/day for ≥ 4 weeks prior to study entry * baseline 25(oh)d concentration of \< 30 ng/ml * willingness to discontinue other vitamin d supplements and/or multivitamins containing vitamin d while participating in the study * age 18 - 85 years * ability to complete questionnaires in english * ability to give informed consent exclusion criteria: * presence of hypercalcemia (\>10.4 mg/dl), hypercalcuria (urinary calcium/creatinine ratio ≥ 0.8 mmol/mmol) or known primary hyperparathyroidism * liver disease (serum alt, ast \>2x normal) or total serum bilirubin \>1.5x normal * history of renal stones * current treatment with any dose of cyclophosphamide * dialysis or creatinine \> 2.5 mg/dl * pregnancy * current drug or alcohol abuse * anticipated poor compliance

Keywords: vitamin d lupus
sleep spindles organization as an early neural marker of neuromotor outcome

Conditions: EEG Sleep Spindles; Motor Outcome; Cerebral Palsy; SMA1

Summary: the goal of this observational study is to test the effectiveness of quantitative early biomarkers in the sleep electroencephalogram (eeg), namely sleep spindles, as predictors of early sensorimotor maturation and long-term motor outcome. spindles are discrete events, prominent over sensorimotor areas, that reflect motor learning overnight consolidation. they represent a potential marker for the investigation of altered early sensorimotor reorganization and long-term motor outcomes in the case of neuromotor pathologies. to test this hypothesis, we will validate the prognostic accuracy of a semi-automated eeg sleep-spindles analysis in two clinical populations: 1) infants with a perinatal brain lesion, at risk of cerebral palsy (cp), 2) infants with spinal muscular atrophy type 1 (sma1), a neuromuscular disease detectable at birth with variable response to early pharmacological treatment. a group of typically developing infants (at very low neurological risk) will be enrolled in the study as control group. all participants will undergo two sleep eeg recordings at 2-5 months (t1) and 12 months (t2), respectively. short-term neuromotor outcome will be evaluated at t1 and t2, through standard and validated assessment. long-term neuromotor development will be defined at 18 months (t3; i.e. cp vs no cp; sma treatment responders vs no responders). primary clinical and motor outcomes will be used for estimating the effectiveness of spindles' features at t1 and t2 as predictors of later clinical and motor outcomes at t3. eeg sleep features will be considered both cross-sectionally, at each time point (t1, and t2), and from a longitudinal perspective. differences in the eeg sleep-spindle features will be evaluated within- and between-groups.


Eligibility criteria:
inclusion criteria: * infants aged 0-5 months who are at high-risk of cerebral palsy (cp): preterm and at term infants with a documented pre- or perinatal brain lesion at the neonatal brain mri (i.e. hypoxic-ischemic brain injury, ischemic or hemorrhagic stroke, cystic periventricular leukomalacia, periventricular hemorrhagic infarction associated with germinal matrix-intraventricular haemorrhage); * infant aged 0-5 months who have received the diagnosis of sma1, according to the perinatal genetic screening, and undergo early pharmacological treatment; * infants aged 0-5 months at very low neurodevelopmental risk (control group): infants born preterm or at term in absence of perinatal neurological complications. exclusion criteria (apply all groups): * presence of drug-resistant epilepsy or active epilepsy at t1, * severe sensory deficits (blindness or deafness) * diagnosis of progressive neurological disorders, other than sma.

Keywords: infant sensorimotor development automatic spindle detector biomarker eeg
geneexpression as a marker of embryo viability

Conditions: Infertility

Summary: the aim of the post doc project is investigate which genes regulate implantation in order to analyze specific proteins and microrna in the spent culture media with the long-term goal of developing a non-invasive method of embryo assessment and selection. this will be achieved by conducting a targeted ngs analysis, based on list obtained from a non-published pilot study. when further validated by q-pcr, the expression of specific micrornas known to influence the final list of genes will be analyzed in the spent culture media and the protein products of the genes recovered from the media will be quantified. the level of specific micrornas and proteins will be related to aneuploidy and implantation potential. if the level of specific microrna and/or proteins correlates with pregnancy, the study will form the basis for developing a clinical applicable precise method of improved embryo selection and thus improved ivf treatment.


Eligibility criteria:
inclusion criteria: * \>5 oocytes retrieved exclusion criteria: * endometriosis